Production hygiene: the packaging process from warehouse to logistics

The ongoing global pandemic makes hygiene an aspect that is more important than ever though it has always been vital in hospitals or laboratories. Apart from onsite measures to protect staff and patients from exposure to infection, this involves high standards of hygiene in medical device manufacturing.

MEDICA-tradefair.com asked Frank Wolfsdorf, specialist for medical technology solutions and sales manager at SOMI medical GmbH in Pforzheim to learn more about the strict requirements in this sector.

Mr. Wolfsdorf, SOMI medical cleans, assembles, and packs medical implants and instruments. What are important aspects to consider in this setting?

Frank Wolfsdorf: Quality is the top priority! Proper implementation of process validations and compliance with the specified operational procedures is extremely important. It’s imperative to carry out all subsequent production steps separately. For us, it means applying the four eyes principle (also known as the two-man rule) and implementing the physical separation of similar items with a likelihood of confusion or same items from different batches. These steps are essential to ensure seamless batch tracking. One aspect people always underrate is the increased mandatory documentation as it is a crucial component in the processing of medical devices. Continuous and ongoing education of our staff members to reinforce their knowledge and understanding of their actions, promote a close identification with their career and the company and bolster quality awareness is key to guaranteeing quality. Organization, cleanliness, and compliance with precisely defined hygiene practices are additional prerequisites to maintain a consistent high level of quality.

What are the difficulties and challenges pertaining to the sterilization process?

Wolfsdorf: This area also comes with explicit guidelines and specifications. We only perform the critical sterilization processes with qualified partners. We manage the sterilization process via on-site audits and continuous monitoring and control of certificates and production documents on behalf of our customers.

Cleanrooms are important in both research and production: What role do they play?

Wolfsdorf: Cleanrooms are production facilities with precisely controlled environments pertaining to particles, microbial number, temperature, or humidity. Contingent on the cleanliness class, DIN EN ISO 14644-1 covers the requirements of air cleanliness in cleanrooms and associated controlled environments and specifies the respective conditions. The standard also defines the specifications for monitoring. Research and production stipulate a classified cleanroom that meets the respective specifications to avoid any potential contamination. Centered on personal accountability, external, qualified service providers conduct a series of tests such as airborne particle counting or biological monitoring in defined audit cycles to ensure cleanrooms operate at their required class or Grade.

What (added) measures did SOMI medical take during the COVID-19 pandemic to minimize the viral contamination risk? Did this include additional air filter or similar purification systems?

Wolfsdorf: COVID-19 affects us all and companies in the healthcare and medical sector are no exception. As companies, our top priority is to protect our employees. It would also have fatal consequences if the virus were to contaminate the implants and instruments of our clients. We take multiple countermeasures to reduce the risk of infections by maintaining a higher standard for hygiene, by providing personal protective equipment, and by conducting daily COVID-19 tests. We also use resources such as air cleaners in many rooms. They release negative ions into the air and activate oxygen to kill viruses, bacteria and germs and remove particles from the air. SOMI medical GmbH visitors are also required to present a current, negative test result or have the option of taking an onsite COVID-19 rapid antigen test. All employees are required to comply with the applicable COVID-19 regulations in self-governance, which also pertains to their personal lives.

What are the latest trends in medical device packaging especially as it affects ​​hygiene and sterilization?

Wolfsdorf: One of the biggest risks to health and recovery hospitals face today result from antibiotic resistant germs. At the same time, surgical instruments are becoming increasingly sophisticated and more complex in application to facilitate better and gentler treatment methods for patients. In most cases, these instruments cannot be reprocessed for reuse. Reprocessing – referring to the cleaning, disinfecting, and sterilizing of instruments – is an expensive endeavor, prompting many users to use single-use, disposable products instead. Facilities usually keep applicable inventory on hand. As a service, we warehouse sterile instruments and implants with a shelf life of up to ten years. In doing so, we help increase the profitability and success of manufacturers and medical equipment suppliers. Thanks to our state-of-the-art sterile warehouse at our Pforzheim location and our affiliated logistics, we can offer our customers the best delivery service in the world.